MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97810

Device Problems Unauthorized Access to Computer System (3025); Noise, Audible (3273)

Patient Problem Sleep Dysfunction (2517)

Event Date 10/26/2009

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that they are hearing voices coming out from their interstim in their stomach.While we've been talking on the call, they said someone is listening in.Patient states they are saying their ins has been hacked. patient states they are coming from out of their stomach, and out of their mouth and through the tv. patient states they have reported this. patient wanted to know if their previous device hasn't been turned off. patient hasmentioned this to the healthcare professional (hcp) and have made complaints about this before. patient states when they are on the phone, their phone blinks and it shows medtronic.They inquired if it's possible that they didn't turn off their first implant and also stated they want to speak to the ceo. patient states they are experiencing this all throughout the day and it echos. patient states this has been going on since they first got their interstim system implanted and mentioned "they are saying the it's the police and sheriffs department that are showing pictures of the ceo on their phone. patient then mentioned the manufacturer patent services agent's voice is sounding like 3 different voices.Patient states they "want to hear from karen and godfreed" and the now they just said they were molested.Troubleshooting was unable to be performed as no troubleshooting to be performed with this type of allegation.Known event issue was reviewed and patient redirected to their  hcp to further address the issue.Additional information was received from the hcp.They stated the cause of the hearing voices from the ins was due to psychiatric issues.Asked what steps were taken to resolve the issue they stated, see their psych provider to discuss further action.No further action will be taken, and device is still in use.Additional information was received from the patient.Patient called back in regards to this case with a continuation of the same issue.Patient still feels as though their ins has been hacked and patient was wondering if the ins was connected to satellite or has an audio feature.Patient is still hearing audio feedback really bad; voices coming from their stomach, out of their mouth and into their phone.Patient said when they think thoughts and when they speak, different people's voices are talking.Patient said while on the call, they could hear them listening in on the conversation.While speaking, patient said the voices said "it's my interstim", they also said, "remy", "grandson" and "ala".Patient said when they listen to music, at the end of the song they will hear a different voice change the lyric and say "ala".Patient said the voices say the same things all day and all night and they can't sleep.They also said that during the song sometimes the different voices would insert "ala" into the lyrics when it wasn't the actual lyric.Patient said they get flashes in their eyes and when they look at their skin and hands, they see numbers.Patient said they are sent pornographic child videos to their personal phone and "they" are pointing that they are child molesters.Patient said they've spoken to their hcp who did not help, as well as the police and the fbi.Patient also said they connected with people who help with cyber bullying and they said they couldn't help.Patient mentioned that every time they've called patient services, patient will receive a photo of that person after they hang up the phone.Patient said they will receive a photo of agent after ending the call.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18185730
• MDR Text Key: 328977877
• Report Number: 3004209178-2023-23084
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/21/2023
• Date Device Manufactured: 08/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 109 KG